Trial | NCT01337466  Report issue

Title

Biodistribution and Dosimetry Evaluation of [124I]FIAU
Biodistribution and Dosimetry of [124i]FIAU in Patients With Prosthetic Joint Infection of The Knee or Hip and Healthy Subjects Using PET-CT Scanning

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    124i-fiau ...

  • Study Participants

    12
This protocol will evaluate the biodistribution and dosimetry of [124I]FIAU in both healthy volunteers and patients with prosthetic joint infections. This pilot study will also investigate the safety and tolerability of [124I]FIAU.
Study Started
Dec 31
2010
Primary Completion
Dec 31
2012
Study Completion
Mar 31
2013
Last Update
Jun 27
2013
Estimate

Radiation [124I]FIAU

This is a single dose study of 2 mCi [124I]FIAU in healthy volunteers or subjects with prosthetic joint infection of the knee or hip who will undergo serial PET-CT scanning.

  • Other names: Fialuridine

[124I]FIAU Experimental

single dose study of [124I]FIAU in healthy volunteers or subjects with prosthetic joint infection who will undergo PET-CT scanning

Criteria 

The following are the main inclusion criteria for all subjects:

Males or females age > 18 years
Informed consent
Subjects with chronic medical conditions such as hypertension and diabetes should be considered stable by the principal investigator
Women should be postmenopausal or surgically sterile
Able to return for all study assessments

In addition, the following main inclusion criteria apply for subjects with suspected prosthetic joint infection:

Operative intervention planned in the 30 days following study enrollment
Prosthetic joint implant in site for more than 3 months prior to enrollment

The following are the main exclusion criteria for all subjects:

Unable to comply with study requirements
Indication in the opinion of the principal investigator for surgery within 48 hours of presentation.
Receipt of any antibiotic therapy in the 2 weeks preceding imaging
Immunosuppression, e.g., human immunodeficiency virus (HIV) infection, s/p organ transplantation, receipt of steroids for > 10 days at > 10 mg of prednisone equivalent daily within the 90 days prior to enrollment
Requirement for any medication that predisposes to lactic acidosis (e.g., metformin, iron, isoniazid and salicylates; see Appendix A)
Requirement for any medication that has potential mitochondrial toxicity, e.g., nucleoside analogues (zidovudine, didanosine, stavudine)
History of an inherited mitochondrial disorder (e.g., Leber's hereditary neuropathy, neuropathy, ataxia, retinitis pigmentosa and ptosis [NARP], myoneurogenic gastrointestinal encephalopathy [MNGIE], myoclonic epilepsy with ragged red fibers [MERFF] and mitochondrial myopathy, encephalomyopathy, lactic acidosis and stroke-like syndrome [MELAS]
Chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
Pre-existing myopathy or neuropathy
Abnormal liver function tests defined as alanine aminotransferase (ALT) > the upper limit of normal (ULN), aspartate aminotransferase (AST) > ULN, gamma glutamyl transferase (GGT) > ULN
Alcohol use > 3 units per day in men or 2 units per day in women or active intravenous drug use
Creatinine clearance < 30 mL/min
Body mass index > 40
Life expectancy < 6 months
Hypersensitivity to iodine
No Results Posted